BEUDAMED
    FDA Recall Terminated

    Abbott Diabetes Care, Precision Point of Care Blood Glucose Test Strips;

    Recall: Z-0998-2011 · Initiated December 22, 2010

    Recall

    Recall Number
    Z-0998-2011
    Event Number
    57524
    Firm
    Abbott Diabetes Care, Inc.
    FEI Number
    3002803444
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 22, 2010
    Posted
    February 9, 2011
    Terminated
    October 25, 2011
    Address
    1360 South Loop Road, Alameda, CA, 94502-7000

    Description

    Abbott Diabetes Care, Precision Point of Care Blood Glucose Test Strips;

    Reason

    Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results.

    Action

    On 12/22/10, Abbott Diabetes Care notified customers via Press Release and letters explaining the reason for the recall and requesting the products be returned.

    Distribution

    Products were released for distribution in US and Puerto Rico.

    Quantity

    359 total lots, 1,000,000 strips per lot.